Cleared Traditional

K103176 - FREQUENCER

K103176 is an FDA 510(k) clearance for FREQUENCER, manufactured by Dymedso, Inc.. The device is a Class 2 Anesthesiology device with product code BYI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K103176 · Dymedso, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
90d
Days
Class 2
Risk

K103176 is an FDA 510(k) clearance for the FREQUENCER. Classified as Percussor, Powered-electric (product code BYI), Class II - Special Controls.

Submitted by Dymedso, Inc. (Springfield, US). The FDA issued a Cleared decision on January 26, 2011 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5665 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K103176

510(k) Number K103176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2010
Decision Date January 26, 2011
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 140d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BYI Device Classification - Class 2, Special Controls

Product Code BYI Percussor, Powered-electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5665
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BYI Percussor, Powered-electric

All 43
Devices cleared under the same product code (BYI) and FDA review panel - the closest regulatory comparables to K103176.
BREATH SHAKE
K121587 · Cheen Houng Ent. Co. , Ltd. · Nov 2013
INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST
K122480 · International Biophysics Corporation · Mar 2013
RESIN 11
K121170 · Respinnovation Sas · Jul 2012
FREQUENCER MODEL V2X
K100749 · Dymedso, Inc. · Aug 2010
FREQUENCER, MODEL 1001
K063645 · Dymedso, Inc. · Mar 2007
LUNG FLUTE
K060439 · Medical Acoustics, LLC · Jun 2006